The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. Additionally, this study will provide preliminary evidence on the impact on health outcomes for patients undergoing interventional catheterization procedures when the xDot AMS is used for vascular closure.
The study is a prospective, multicenter, dual-cohort, single-arm, open-label IDE pivotal trial enrolling patients undergoing catheter-based interventional procedures requiring large bore femoral arterial or femoral venous access, comprising: * A single-arm Femoral Arterial cohort for evaluation of the xDot AMS for closure of femoral arterial access sites ("Femoral Arterial cohort"), and * A single-arm Femoral Venous cohort for evaluation of the xDot AMS for closure of femoral venous access sites ("Femoral Venous cohort") The study includes a roll-in cohort consisting of treatment-only subjects, which will be analyzed and presented separately and will not contribute to the pivotal analysis populations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
266
The xDot AMS is designed to deliver the xDot Implant Unit around the access site on the target vessel to close the puncture site.
Freedom from major complications of the target access site for Femoral Arterial cohort
Time frame: 30 days post-procedure
Time to hemostasis (TTH) for Femoral Arterial cohort
Defined as the elapsed time from procedural sheath removal to the first observed cessation of common femoral artery bleeding (excluding cutaneous or subcutaneous oozing at the access site)
Time frame: During procedure
Freedom from major complications of the target access site for Femoral Venous cohort
Time frame: 30 days post-procedure
Time to hemostasis (TTH) for Femoral Venous cohort
Defined as the elapsed time from procedural sheath removal to the first observed cessation of common femoral vein bleeding (excluding cutaneous or subcutaneous oozing at the access site).
Time frame: During procedure
Time-to-ambulation (TTA) for Femoral Arterial cohort
Defined as the elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
Time frame: 48 hours post-procedure
Time-to-ambulation (TTA) for Femoral Venous cohort
Defined as the elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
Time frame: 48 hours post-procedure
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